KR20160055103A - System and signatures for the multi-modal physiological stimulation and assessment of brain health - Google Patents

System and signatures for the multi-modal physiological stimulation and assessment of brain health Download PDF

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KR20160055103A
KR20160055103A KR1020157029845A KR20157029845A KR20160055103A KR 20160055103 A KR20160055103 A KR 20160055103A KR 1020157029845 A KR1020157029845 A KR 1020157029845A KR 20157029845 A KR20157029845 A KR 20157029845A KR 20160055103 A KR20160055103 A KR 20160055103A
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data
biological
user
brain
stimulation
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KR1020157029845A
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Korean (ko)
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아담 제이 사이먼
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아담 제이 사이먼
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Priority to US61/799,842 priority
Priority to US201361836294P priority
Priority to US61/836,294 priority
Priority to US61/932,915 priority
Priority to US201461932915P priority
Application filed by 아담 제이 사이먼 filed Critical 아담 제이 사이먼
Priority to PCT/US2014/028061 priority patent/WO2014143896A2/en
Publication of KR20160055103A publication Critical patent/KR20160055103A/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/02Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/024Detecting, measuring or recording pulse rate or heart rate
    • A61B5/02405Determining heart rate variability
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/04Measuring bioelectric signals of the body or parts thereof
    • A61B5/0476Electroencephalography
    • A61B5/0478Electrodes specially adapted therefor
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/04Measuring bioelectric signals of the body or parts thereof
    • A61B5/0476Electroencephalography
    • A61B5/0484Electroencephalography using evoked response
    • A61B5/04842Electroencephalography using evoked response visually
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/04Measuring bioelectric signals of the body or parts thereof
    • A61B5/0476Electroencephalography
    • A61B5/0484Electroencephalography using evoked response
    • A61B5/04845Electroencephalography using evoked response acoustically or auditory
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/04Measuring bioelectric signals of the body or parts thereof
    • A61B5/0476Electroencephalography
    • A61B5/0484Electroencephalography using evoked response
    • A61B5/04847Electroencephalography using evoked response olfactory or gustatory
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/05Detecting, measuring or recording for diagnosis by means of electric currents or magnetic fields; Measuring using microwaves or radiowaves
    • A61B5/053Measuring electrical impedance or conductance of a portion of the body
    • A61B5/0531Measuring skin impedance
    • A61B5/0533Measuring galvanic skin response, e.g. by lie detector
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/103Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb
    • A61B5/1118Determining activity level
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    • A61B5/14542Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring blood gases
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    • A61B5/163Devices for psychotechnics; Testing reaction times ; Devices for evaluating the psychological state by tracking eye movement, gaze, or pupil change
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Detecting, measuring or recording for diagnostic purposes; Identification of persons
    • A61B5/40Detecting, measuring or recording for evaluating the nervous system
    • A61B5/4058Detecting, measuring or recording for evaluating the nervous system for evaluating the central nervous system
    • A61B5/4064Evaluating the brain
    • AHUMAN NECESSITIES
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    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
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    • A61B5/40Detecting, measuring or recording for evaluating the nervous system
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    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6802Sensor mounted on worn items
    • A61B5/6803Head-worn items, e.g. helmets, masks, headphones or goggles

Abstract

Diagnostic signatures and systems derived from data collected in the system capture multiple streams of biological sensor data for assessing the user's brain health and function. The system includes a plurality of biological sensors capable of stimulating the brain with various sensory, cognitive, physical, and chemical tests as well as being intended to collect biological sensor data from the user. Biological sensors can be used to measure balance and movement accelerometers, microphone and voice response and response measurements, image sensors and biometric identification to track eye movements, heart rate, heart rate variability, and arterial oxygen measurement, In addition to one or more additional biological sensor data streams selected from the Galvanic Skin Conductance (or dermal conductance) for the atmospheric information, the key press during the recognition test, and the perception data in the form of a mouse click or screen event touch, And an active EEG sensor that collects one or more channels of EEG data. Several of the biological sensors are housed in an electronic module mounted on the user's head.

Description

[0001] SYSTEM AND SIGNATURES FOR MULTI-MODE PHYSIOLOGIC DRUG AND EVALUATION OF BRAIN HEALTH [0002]

<Cross reference to related application>

This application claims the benefit of U.S. Provisional Application No. 61 / 799,842, filed March 15, 2013, U.S. Provisional Application No. 61 / 836,294, filed June 18, 2013, and U.S. Provisional Application, filed January 29, Claim 61 / 932,915 for the benefit of priority. The entire contents of these patent applications are incorporated herein by reference in their entirety.

The present invention relates to diagnosing and analyzing brain health through active tasks and stimulation within the system to dynamically evaluate human brain conditions and functions.

Normal functioning of the brain and central nervous system is essential for a healthy, enjoyable, productive life. Disorders of the brain and central nervous system are among the most feared diseases. Many neurological disorders, such as stroke, Alzheimer &apos; s disease, and Parkinson's disease, are slowly spreading, progressive, and becoming more and more common as they get older. Other diseases such as schizophrenia, depression, multiple sclerosis and epilepsy can develop at an earlier age and last for an individual's lifetime. Rapid damage to the nervous system, such as brain trauma, infection and poisoning, can also affect an individual at any time, regardless of age.

Most neurological dysfunctions result from the complex interactions between each individual's genotype, environment, and personal habits, and are therefore often manifested in very individual forms. However, despite the increasing importance of preventive health, the means to objectively assess the health of the person's nervous system has not been widely used. Accordingly, new methods for monitoring the health status of the brain and nervous system are required for monitoring normal health status, early diagnosis of dysfunction, tracking of disease progression, discovery and optimization of new therapies and therapies.

Unlike cardiovascular and metabolic disorders, where biomarkers for personal health monitors such as blood pressure, cholesterol, and blood sugar have become family-level controls, these convenient biomarkers for brain and nervous system health does not exist. Quantitative neurophysiological assessment approaches, such as positron emission tomography (PET), functional magnetic resonance imaging (fMRI), and neuropsychiatry or cognitive testing, require significant operator expertise, inpatient or clinic-based testing, It costs money. One potential technique that can be applied to perform a broader role as an easy biomarker of nervous system function is to use a variety of electroencephalography (EEG) techniques to measure the brain's ability to generate and transmit electrical signals And evaluating the brain in a multimode form from different types of data. However, the formal laboratory-based EEG approach typically requires significant operator training, troublesome equipment, and is mainly used for epilepsy testing.

An alternative and innovative biomarker approach is desired for quantitative measurement of individual brain health that can significantly improve the prevention, diagnosis and treatment of neurological and mental disorders. Unique multimode devices and tests, which range from Parkinson's disease, Alzheimer's disease, concussion, and other neurological and neuropsychological conditions to biomarkers, are in desperately needed.

Diagnostic signatures and systems derived from data collected within the system address the need in the art by capturing multiple streams of biological sensor data to assess a user &apos; s brain health and function. In an exemplary embodiment, the system includes a plurality of biological sensors configured to collect biological sensor data from a user, as well as the ability to stimulate the brain with various sensory, cognitive, physical, and chemical challenges. Biological sensors include an active EEG sensor that collects one or more channels of EEG EEG brainwave data as well as one or more additional biological sensor data streams. These sensor data streams may include, but are not limited to, accelerometer measurements of balance and motion, microphone measurements of voice and response, image sensors to track eye movement and biometric identification, heart rate by pulse oximetry measurements, And cognitive data in the form of an arterial oxygen measurement, a galvanic skin response (or dermal conductance) for emotion and mood information, a key press during a cognitive test, and a mouse click or screen event touch. Finally, medicines, ingredients, and compounds approved by the regulatory body can be dosed into diagnostic capacity to test the brain and can be measured by diagnosis.

In one embodiment, the system includes only one reusable electronic module (REM) close to the brain to record various biological signal stream data. This is complemented by a variety of biological signal streams collected simultaneously in peripheral MCUs in the form of devices such as laptop computers, tablet PCs or smart phones.

In another embodiment, the system includes one or more REM modules in addition to the REM module on the head. In this embodiment, the REM module, which is not placed on the head, is positioned in the torso of the human body to collect heart rate and position information, or alternatively or additionally, to the wrist or ankle for recording biological signals from the distal end of the individual . In any case, the data can be analyzed in any one of the ways that the data are registered together in time and the respective aspects or biological signals are analyzed independently or correlated. A multivariate predictive statistical model can be embedded with diagnostic information to aid the health and well-being of the body under evaluation.

The system also has a means to stimulate the human body being evaluated to respond to sensory, cognitive, physical, and chemical tests. In one embodiment of the present invention, the visual system is evaluated to either (i) a light stimulus from either a peripheral MCU or head REM, or (ii) an image or movie displayed on a video screen of a peripheral MCU. In another embodiment, the hearing system is tested with binaural bits, mono-auditory bits, isochronic tones or other significant auditory stimuli with known or expected biomarker signatures in various data streams. In another embodiment, the anillometer is directly stimulated by a single serving special formula product or, alternatively, by a device that electrically stimulates the tongue. In another embodiment, the posterior system is stimulated through a direct electrical stimulation to a scratch and sniff card, an automatic perfume delivery system, or posterior nerve. Finally, the tactile sense can be stimulated through known textures or through direct transcutaneous electrical stimulation. Either one of these embodiments may be practiced, or may be advantageously implemented in combination if desired, all of which are part of the invention.

An alternative embodiment of the present invention includes various multi-contact electrodes, whereby a standard circle or square is evenly divided into two, three, or four independent electrodes. By doing so, the two electrode systems of the present invention can be 4, 6, or 8 electrode systems within the same spatial and temporal arrangement, including the form factor of the headband.

One embodiment uses a disposable air pillow or cushion, or other compact, inflatable device, to form an irregular or unstable surface and allow the body to balance thereon to assess static balance / stability, Balance / stability.

In another embodiment, an additional data converter is embedded in the REM module so that the system can obtain various streams of biological sensor data. Certain specific embodiments include having an acoustic microphone and / or a forward facing digital image sensor (essentially a movie camera).

Other embodiments include the use of either an image sensor for image processing induced eye tracking and motion, or a dedicated device or technique such as a Google Glass eye tracker or an infrared based eye tracker.

In another embodiment, the REM is designed to have a mass storage device such as a micro SD card or other high density RAM storage unit. This RAM storage unit makes it possible to collect data from the REM directly into the mass storage without having to make a wireless connection to the peripheral MCU.

In another embodiment of the present invention, photographic images with unique emotional, valence-based characteristics are shown in the human body, during which their biological signals are measured and recorded. In this case, those who do not have normal emotional response to whimsical images (pigs on the sea) can be objectively detected by the biological sensor data stream. Other mood and emotional information may also be advantageously collected. In certain embodiments, EEG and accelerometer measurements are collected while electrophysiological response (GSR) measurements are collected while photographic images are presented. This can work not only for static images but also for dynamic images such as movies.

BRIEF DESCRIPTION OF THE DRAWINGS Embodiments of the invention may be better understood with reference to the following drawings.
1 is a schematic diagram illustrating a human body having a plurality of REM modules as well as a nearby peripheral microprocessor (MCU) directly or wirelessly accessed for electronic medical records.
2 is a schematic diagram illustrating that data from a human being wearing a headset is delivered to a laptop, tablet or smart phone, in which case the data is encrypted and sent to the cloud.
Figure 3 is a schematic diagram illustrating how an encrypted data package arrives, decodes, undergoes signal preprocessing for artifact detection, and then passes through various signal processing modules for biometric feature set tables and predictive analysis.
4 is a schematic illustration of a diagnostic method as a service system.
5 is a schematic illustration of a series of nine different biosignals from a multi-mode stimulus and data acquisition system.
Figure 6 is a schematic illustration of a series of nine different biological signals from a multi-mode stimulus and data acquisition system. (Note: Composite data not from a real human body)
Figure 7 is a schematic illustration of a one-channel compliant device.
Fig. 8 is a schematic illustration of a headband in which electrodes are staggered in each temple.
Figure 9A is a schematic illustration of a single circular or square electrode having two adjacent electrodes evenly divided into the same amount of space.
Figure 9b is a schematic illustration of a single circular or square electrode having three adjacent electrodes evenly divided into the same amount of space.
Figure 9c is a schematic illustration of a single circular or square electrode having four adjacent electrodes evenly divided into the same amount of space.
10 is a schematic illustration of an electronic module supported by a headband as a module with both a microphone and a miniature camera incorporated therein.
Figure 11 is a schematic illustration of an apparatus such as Google Glass with infrared eye tracking capability.
Figure 12 is a schematic illustration of an electronic module supported by a headband, with both an arrayed LED point light source for light stimulation and a dual LED, tri-color montage LED.
Figure 13 is a downward schematic view of an electric tongue stimulator for the brain.
14 is an enlarged view of a downward schematic view of an electric tongue stimulator for the brain.
15 is an enlarged view of a downward schematic view of an electric tongue stimulator for the brain with the availability of a sterilizing package through a disposable covering, which is reusable of the main electrical components;
16 is a downward schematic view of an electric nose stimulator for the brain.
17 is a downward schematic view of an electric nose stimulator for the brain with a disposable covering to enable reuse of the main electrical component.
Figure 18 is a graphical representation of a pair of graphical displays of a logistic plot and corresponding receiver operating characteristic curve (ROC), wherein the ROC is an EEG feature (relative beta) used to predict a clinical diagnosis of a concussed object for a control subject; Of ROC.
Figure 19 shows the results of a King-Devick test as a combination of two predictive models according to the invention, in combination with two co-variates, age and sex (subplot) or as a pair (top plot) Is a graphical display of a pair of receiver operating characteristic curves (ROC) for EEG features (relative beta) combined with cognitive task scores from the user. The Area Under the Curve (AUC) is also shown.
20 is a graphical representation of the rated symptom checklist total score (along the y-axis) when performing consecutive evaluations with several different scans, as indicated along the x-axis at scan visit for N = 18, The flat trajectory appears to be symptomless, while some subjects appear to have symptoms due to a concussion.
21 is a graphical representation of the concordance standard assessment (SAC) total score (along the y-axis) when successive evaluations were made with several different scans as indicated along the x-axis at scan visit for N = 18, The flat trajectory appears to be close to 30 (perfect score), and seems to be cognitively intact, while some objects seem to represent cognitive problems due to concussion.
Figure 22 shows the results of the Balance Error Scoring System (BESS) (when viewed along the y axis) when a continuous evaluation was performed with several different scans as indicated along the x axis during a scan visit for N = 18, The graph shows the total error score. The flat trajectory appears to be close to zero (zero) and their vestibular system appears stable, while some subjects appear to exhibit balance and vestibular problems due to concussion.
Figure 23 shows the minimum error triplet (3) test card (sec) (sec.) Along the y axis when N = 18, i.e. 18 consecutive evaluations with several different scans as indicated along the x- (1986), which were measured within the total time span over the entire time frame. While a flat trajectory close to 40 seconds appears to be consistent and stable neuroanatomical treatment, some subjects appear to have a longer time to concussion on initial scan visits.
Figure 24 is a graphical representation of a ranked symptom checklist total score (as measured along the y axis) when performing consecutive evaluations with several different scans, as indicated along the x axis during a scan visit for N = 18, Uninjured team members (green traces) who pair up with concussion subjects (red traces) or perform the same scan sequence to function as controls are paired together.
25 graphically illustrates the total score of a standard concussion evaluation (SAC) (along the y-axis) when successive evaluations were made with several different scans as indicated along the x-axis during a scan visit for N = 18, . Uninjured team members (green traces) who pair up with concussion subjects (red traces) or perform the same scan sequence to function as controls are paired together.
Figure 26 shows the results of the Balance Error Scoring System (BESS) when running continuously on several different scans as indicated along the x axis at scan visit for N = 18, i. E. The graph shows the total error score. Uninjured team members (green traces) who pair up with concussion subjects (red traces) or perform the same scan sequence to function as controls are paired together.
Figure 27 shows the minimum error triplet (3) test card (sec) (sec.) Along the y axis when N = 18, i.e. 18 consecutive evaluations with several different scans as indicated along the x- (1986), which were measured within the total time span over the entire time frame. Uninjured team members (green traces) who pair up with concussion subjects (red traces) or perform the same scan sequence to function as controls are paired together.
Figure 28 shows the relative beta EEG during the course of the task while closing the eyes (along the y axis) when several consecutive evaluations were made with several different scans, as indicated along the x axis at scan visit for N = 18, Graphically. Uninjured team members (green traces) who pair up with concussion subjects (red traces) or perform the same scan sequence to function as controls are paired together.
Figure 29 shows the baseline (scan visit 0) for N = 6 with 6 baseline (i.e., along the x axis) and the graded symptoms (along the y axis) It is a graphical representation of the checklist total score. Athletes with concussion are on the left panel, while controls without injury are on the right panel.
Figure 30 shows a standard concussion evaluation (according to the y-axis) when a baseline (scan visit 0) and a scan visit 1 consecutive evaluation (along the y-axis) for N = 6 with 6 baseline SAC) is a graphical representation of the total score. Athletes with concussion are on the left panel, while controls without injury are on the right panel.
Figure 31 shows the baseline (scan visit 0) for N = 6 with 6 baseline (i.e., along the x axis) and the balance error score system (along the y axis) (BESS) is a graphical representation of the total error score. Athletes with concussion are on the left panel, while controls without injury are on the right panel.
Figure 32 shows the baseline (scan visit 0) for the N = 6 with 6 baseline (i.e., the x axis) and the minimum error triangle (along the y axis) 3) a graphical representation of the King-Devic eye and test (Orew et al., 1986) measured within the total time span of the test card (sec. Athletes with concussion are on the left panel, while controls without injury are on the right panel.
Figure 33 shows a graphical representation of the baseline (scan visit 0) and scan visit 1 (for x = 6) with N = 6 baseline, It is a graphical representation of the relative beta EEG during the course. Athletes with concussion are on the left panel, while controls without injury are on the right panel.
Figure 34 shows four uninjured control (CTL) cells for each scan visit (along the x axis) such that the GSC, SAC, BESS, KD time, and relative beta power (along the y axis) It is a graphical representation of the human body. This is useful for going back to the decision making stage.
Figure 35 shows four consecutive concave (TBI) bodies, one for each of the scan visits (along the x axis) and the other for the GSC, SAC, BESS, KD time, and relative beta power Graphically. This is useful for going back to the decision making stage.
36 shows one uninjured control group (CTL) such that GSC, SAC, BESS, KD time, and relative beta power (along the y axis) are individually stacked for each scan visit (along the x axis) It is a graphical representation of a human body and a person with a concussion (TBI). This is useful for going back to the decision making stage.
37 is a schematic illustration of a laptop or tablet PC. An external eye tracker is shown below the video monitor and is connected via wire (e.g., USB) or wirelessly (e.g., Bluetooth, ZigBee, WiFi).
38 is a graphical representation of a 30-Hz output eye tracker that moves the eye around the edge of the screen, from upper left to upper right, lower right, lower left, back to upper left when a series of cards is presented. The origin of the coordinate system is the upper left corner of the computer screen.
Figure 39 is a graphical representation of the amount of time the eye of the research subject has focused on the number on the stimulus card. This data complements EEG, speech, and neuropsychological data.
Figure 40 is a graphical representation of the amount of time the eye of the research subject has focused on the number on the stimulus card. This figure also shows the established Areas of Interest (AOI), which allows you to determine how much time is spent in the AOI for a variety of external AOIs. This data complements EEG, speech, and neuropsychological data.
41 is a graphical representation of the graded symptom checklist total score (as measured along the y-axis) when successive evaluations were made on several different scans, as indicated along the x-axis at scan visit for N = 40, The flat trajectory appears to be symptomless, while some subjects appear to have symptoms due to a concussion.
Figure 42 is a graphical representation of the concordance standard assessment (SAC) total score (along the y-axis) when successive assessments were made with several different scans, as indicated along the x-axis during a scan visit for N = 40, The flat trajectory appears to be close to 30 (perfect score), and seems to be cognitively intact, while some objects seem to represent cognitive problems due to concussion.
Figure 43 shows the total error score of the Balanced Error Scoring System (BESS) when running consecutively on several different scans as indicated along the x axis during scan visit for N = 40, or 18, . The flat trajectory appears to be close to zero (zero), and while their precursors appear stable, some objects appear to represent balance and vestibular problems due to concussion.
Figure 44 shows the minimum error triplet (3) test card (sec) (as measured along the y-axis) when successive evaluations were made with several different scans as indicated along the x-axis at scan visit for N = 40, (1986), which were measured within the total time span over the entire time frame. While a flat trajectory close to 40 seconds appears to be consistent and stable neuroanatomical treatment, some subjects appear to have a longer time to concussion on initial scan visits.
Figure 45 shows the minimum error triplet (3) test card (sec) (as measured along the y-axis) when successive evaluations were made with several different scans as indicated along the x-axis at scan visit for N = 40, (O'Reilly et al., 1986), measured within the total time span of time, and the subjects are shown as a pair of an uninjured athlete and an injured athlete. While a flat trajectory close to 40 seconds appears to be consistent and stable neuroanatomical treatment, some subjects appear to have a longer time to concussion on initial scan visits.

Hereinafter, the present invention will be described in detail with reference to Figs. 1 to 45. Those of ordinary skill in the art will understand that the description provided for these figures is for illustrative purposes only and is not intended to limit the scope of the invention in any way. All questions regarding the scope of the invention can be resolved by reference to the appended claims.

[Justice]

"Electrode to scalp" means to include, without limitation, electrodes requiring gel, dry electrode sensors, non-contact sensors, and any other means of measuring self-evoked potentials or potentials by electromagnetic means do.

"Brain and neurological monitoring" includes, without limitation, monitoring normal health conditions and aging for the discovery and optimization of therapy and pharmacotherapy, early detection and monitoring of brain dysfunction, monitoring of brain injury and recovery, Including, but not limited to, the monitoring of test compounds and registered medicines, as well as the effects of, or the presence of, illegal substances on individuals during driving, sports activities, or other regulated activities, Of the monitor.

As used herein, "medical therapy" includes, but is not limited to, any drug or treatment, compound, biologics, medical device therapy, exercise, biofeedback or any combination thereof, It is intended to include forms of therapy.

"EEG data" may include, without limitation, a raw time series, any spectral characteristics determined after Fourier transform, any nonlinear characteristics after nonlinear analysis, any wavelet characteristics, any summary biometric variables, Quot; means any combination of these.

As used herein, the "sensory and cognitive challenge" refers to any form of sensory stimulation, cognitive testing (respiratory CO 2 test, virtual reality balance test, knee reflex) Hammer tests, etc.). &Lt; / RTI &gt;

As used herein, the "sensory and cognitive test state" is intended to include any state of the brain and nervous system during exposure to sensory and cognitive testing.

As used herein, "electronic systems" include, but are not limited to, hardware, software, firmware, analog circuits, DC coupled or AC coupled circuits, digital circuits, FPGAs, ASICS, visual displays, audio converters, temperature transducers, Or any combination of the above.

The "spectral band" means a definition commonly accepted in standard document practice without limitation, and the PSD band is often referred to as the delta band (f <4 Hz), the Theta band (4 <f < 12Hz), a beta band (12 <f <30Hz), and a gamma band (30 <f <100Hz). The exact boundaries of these bands depend on some interpretation and are not invariant to all practitioners in the field.

"Calibrating" refers to the process of making known inputs in the system to adjust the internal gain, offset, or other adjustable parameters to place the system in a quantitative state of reproducibility.

"Performing quality control" means performing an evaluation of a system with a known input signal and verifying that the output of the system is equal to expected. In addition, confirming the output for a known input reference signal is one form of quality control to ensure that the system was in good working condition either before or at the time the data block was collected for the human body.

"Biomarker" means an objective measurement of a biological or physiological function or process.

A "biomarker feature or metric" refers to a variable, biomarker, indicator, or characteristic that characterizes some aspect of raw underlying time series data. These terms can be used in equal and compatible manner with biomarkers as objective measures.

By "non-invasive" is meant that there is no need to penetrate the human skin or tissue.

"Diagnosis" includes classifying an object into a category group, assisting in diagnosis when used with other additional information, blocking at a higher level where no a priori evidence exists, being used as a prognostic marker, Or as an injury progress marker, a therapeutic response marker, or even a therapeutic monitoring endpoint.

An "electronic module" or "EM" or "reusable electronic module" or "REM" or "multifunctional biosensor" or "MFB" can be used to record biological signals from the same human body or a plurality of human bodies at different times Means an electronic module or device. The same term also refers to a disposable electronic module that can be used and discarded once, which can become part of the future as miniaturization becomes increasingly common and production costs decrease. An electronic module may have only one sensing function or a plurality (one or more), and the latter (more than one) is more common. These terms are all equivalent and do not limit the scope of the invention.

A "biosignal" or "biosignal" or "bio-signal" refers to any direct or indirect biological signal measurement data stream derived directly from or derived from the human body being evaluated. Non-limiting examples of illustrative purposes include, but are not limited to, physical motion or balance derived from EEG brainwave data recorded directly or indirectly from the scalp, core temperature, accelerometer, gyrometer, and magnetic compass, The acoustic sound from the microphone, the camera video stream from the camera towards the front, the heart rate, the heart rate fluctuation, and the arterial oxygen from the would pulse oximeter, the skin conductivity measured along the skin, And recorded cognitive task information according to a click or a touch of a screen event. There are also many other bio-signals to be recorded.

"Return to Play" can be used to return to the previous state to resume an activity that was essentially the body's previous involvement, such as returning to duty, returning to work, returning to work, returning to work, returning insurance coverage, A similar decision, such as a decision based on the return of any activity that is the same problem as trying to return.

Multiple transducer systems to stimulate and record physiological brain responses

The systems and methods of the present invention include a plurality of transducers that stimulate and record physiological responses of the brain and body to assess their health and function. Most important to the system is the ability to record non-invasive EEG activity directly on or near the scalp from the electrode site. Further information on brain health and function may be derived from transducers measuring cardiovascular characteristics, location and movement, temperature, such as heart rate, heart rate variability, and arterial oxygen, and may include additional biological signal measurements Some examples of data streams are cognitive information, speech, eye movement, and surface skin conductivity. Often bringing the system out of the hospital or office and bringing the system to the human body to enable data collection at the home, at the athletic field, or on the battlefield stage, thereby enabling access to brain health and functional assessment from lightweight portable form factors . It would also be advantageous if the system could be used globally to help those in need of a minimum brain health and functional assessment, with a minimum cost associated with the system.

Solutions to these problems include body-worn or body proximity electronic modules (EMs or REMs) systems with the ability to record biological signal measurement data streams as well as stimulate the body in the form of various sensory and cognitive tests and tasks . In particular, one such electronic module (EM or REM) may be located near the head, which can be reused continuously if not in contact with the human body, or disposable when in direct contact with the human body.

In one embodiment of the system, as shown in Figure 1, the human body 3 can be mounted with an electronic module or reusable electronic module (REM) 5 on its head 4. [ The electronic module 5 comprises several sensors and a transducer therein to stimulate the human body and to provide a biologically precisely processed microprocessor with software embedded in the REM on the local microprocessor control unit (MCU) Record the signal measurement data stream ("bio signal"). In this system, a limb (6) in the form of an arm or a rim (7) in the form of a leg can hold an additional REM module (8 or 10) DMF for further reading and acquisition of additional biological signals . If desired, the REM module 9 is located on the torso of the human body, or on the side of the chest or around the neck. Connected or near the air interface, the peripheral MCU 11 not only controls the standardized application of sensory and cognitive stimuli, but also coordinates a wide range of data acquisition of biological signals derived from the human body. The peripheral MCU 11 will be reminiscent of a laptop, a tablet PC, or today's smartphone, but perhaps the human body is in a different position from that placed in an audio-video environment such as a home theater with video, sound, and other sensory stimuli It may be placed. REM modules are consequently considered to be able to interface with each other through newer RF technologies that enable long-distance communications with large bandwidths. Significantly, the peripheral MCU 11 may make database connections locally to the mass storage device, such as the hard drive 13, via the hard wire 12, or alternatively, May also be coupled to the remote mass storage device 15 via an interface 14 (e.g., by way of example, but not limited to, an ethernet cable, a WiFi, a cellular data modem, a satellite data modem). The purpose of accessing the database is to pull genetic information or other laboratory results into the system, including non-limiting examples such as blood type, last recorded blood pressure, or ApoE genotype status, to make the predictive signature more accurate or precise ) It should be noted that the system of the present invention may be implemented in an electronic record that may reside at any other location or from an electronic record that is locally downloaded to the peripheral MCU 11 or available via the network connection 14 to the remote database 15 It is possible to access additional information about it and extract it. In either case, when an unusual patient identification number is entered and appropriate security measures are taken (such as authentication via two factors), many additional data variables are extracted from the database records stored on mass storage devices 13 and / I can get out.

Another embodiment of the invention includes a data recording and analysis system comprising at least one REM located on the head of a human body for recording a brain related biological health signal, a peripheral MCU, and a cloud for processing and reporting the collected data Based enterprise information technology infrastructure. In particular, FIG. 2 illustrates an electronic REM module 306 on the head of a human body that transmits wireless data to a peripheral MCU 304 (in the form of a tablet PC). While the data is collected through the Bluetooth port in the MCU, the camera 300 not only identifies the human body, but also when they perform tasks to analyze their eye and facial movements of interest features (including intermittent motion) The image of the human body is recorded as a movie. The built-in accelerometer and gyrometer 302 measure the stability or lack thereof of the human body while the microphone 312 records voice of the human body for speech recognition analysis while the touchscreen 304 of the peripheral MCU measures the spatial (x, y) position and precise time. Finally, when all of the various data streams are complete, the entire information package, along with population and personal health information, is transferred from 310 to a virtual or remote based server over an Internet connection 314, which can be virtually WiFi, Ethernet, Is encrypted locally using AES-128 or AES-256 bit encryption (or equivalent security measures) 308 before being transmitted.

When data is received by the virtual server 320 connection, it is decrypted by a suitable algorithm in the key 322, as shown in FIG. 3, and then transmitted to the mobile station 100 in accordance with US Provisional Application No. 61/773428, filed March 6, Such as eye blinking, drop outs, saturated rails, artifacts, EKG artifacts, or other known artifacts 324, as disclosed in US patent application Ser. Data is sent for preprocessing. Once artifacts are identified and characterized, a good data region for each of the various data streams is passed through the signal processing software to extract candidate features from each of the available data streams. In particular, a spectral analysis or FFT module 326 is applied to the data signal, a nonlinear dynamic module 328 is applied, and a wavelet transform module 330 is applied. Once each module has extracted the associated candidate features from each data block, the software then gathers the extracted biometric feature table 332. The feature table 332 includes each candidate feature from each data stream and also includes a list of features as diagnostic features that are possible. From the biometric feature table 332, a prediction analysis 334 is performed on an unknown object and the prediction model classifies the object into one of several groups or classes, or alternatively, do. This information is then compared to baseline / migration data from the same subject or from normative data of a demographically matched population, and a report 336 is generated. This report 336 is then sent electronically to the physician 338 who can interpret the report remotely. The physician's interpretation is provided before being sent back to the treatment point by the healthcare provider who originally acquired the data.

The artifacts detected in the pre-processing module may be used as such to classify unknown human body information according to a validated multivariable predictive statistical model as disclosed in U.S. Provisional Application No. 61/773428, the disclosure of which is incorporated herein by reference in its entirety It is also pointed out that it can be used as a candidate feature to help regression.

4 shows an alternative example in which an active sensor remote electronic module (REM) 350 is mounted with an ear clip 352 on the head of the human body. Bluetooth or other local connection means 354 sends the data to the peripheral MCU 356 (laptop, tablet or smart phone), whereby the data is encrypted and sent to the network 358 via an Internet, cellular or satellite connection . Once entering the virtual remote server 360, the data is automatically decrypted and processed 362 remotely from the data processing center 364. Once pre-processing, signal analysis, and predictive modeling are complete, the system automatically generates 366 a report 368. This report is sent to the appropriate physician (370) for interpretation prior to being sent back to the treatment site to ensure that the physician remains part of the diagnostic cycle, or to the treatment site upon request of the appropriate physician (370).

Looking closely at the outputs from various sensors and transducers mounted on or near the human body, we can see the quantitative output from each sensor or transducer after analog-to-digital conversion by the ADC towards the discrete flow of digital information have. Figure 5 schematically shows the outputs from nine sensors and transducers (artificial data formed for illustrative purposes). Each output is labeled Signal 1 through Signal 9. This example does not include data from other biological signal measurement data streams, such as forward facing imaging cameras, pulse oximetry, skin conductivity measurement, as some non-limiting examples that are not included. In Figure 6, each of the generic sensor labels is replaced by an exemplary biosignal stream (having the same artificial data formed for illustrative purposes). From the top of FIG. 6, a microvolt (μV) of EEG or EEG implemented on the y-axis is shown for a time (t) function along the x-axis. In the second trace, neuro psychological perception data is plotted. The plot shows that the discrete response "event" for a computer neuropsychological test may be at a location (e.g., a mouse click on a keyboard, a mouse click with a location (x, y) on the screen of a video monitor, x, y) is obtained in accordance with a touch event (x, y, t) written in (x, y) space pairs at a given time t. In the following three traces (third, fourth, and fifth from the top), a 3-axis digital accelerometer or a 3-axis analog accelerometer labeled Ax (g), Ay (g), and Az Three independent traces are shown. The acceleration is often expressed as a fraction or a multiple of the gravitational acceleration constant g = 9.8meter / second 2 . In the sixth trace from the top (or fourth below), a microphone recording trace labeled with Voice (mV) is shown, which allows for many different sampling frequencies, but is typically 1 or 2 bytes per sample and is 5Ksam / sec or 8Ksam / sec or 12 or 16 Ksam / sec. In the third trace below labeled with Temp (F), the temperature of the human body is configured over time to investigate whether sensory stimulation or cognitive task affects core body temperature. Finally, the two lower traces are named Ax-2 (g) and Ay-2 (g), located on the constricted part of the chest or waist in the torso, or on the limb around the wrist or ankle Two of the three axes of the accelerometer data from the second REM are illustratively shown. As long as it is well-registered in time, multiple streams of biological signals will enable several more sophisticated and interesting techniques for data acquisition and analysis.

A simplified form factor for acquisition of multiple streams of biological signaling data in brain health and functional assessment,

The system and method of the present invention not only stimulates a variety of sensations but also can be easily positioned in the human body to collect a plurality of bio signals and can be partially reused and partially disposable, And equipment and equipment form factors that can be used locally. Often, for any item in contact with the test body, it is necessary to ensure its integrity and aseptic properties by disinfecting the applied parts or by using new, unused sterilizing set materials that will remove the old and come into contact with the human body. It would also be advantageous to minimize the cost associated with disposable parts that would be thrown away into the trash.

The solution to these problems includes creating one or more electronic modules (EM) or reusable electronic modules (REM) or multifunctional biosensors (MFB) that can be placed on the body to record biosignals from the body . In particular, one such EM module can be placed near the head, can be reused continuously if it does not touch the human body, or can be disposed of if it touches the human body.

In the embodiment shown in Fig. 7, the form factor of the present invention is an electronic module with an active EEG sensor 5 that is directly seated on the forehead or a headband 2 (Fig. 7) supporting a reusable electronic module ). An ear clip 7 (not shown) including a different input signal to a portion of the body other than the skull, preferably somewhere accessible, e.g., one conductor or two conductors (REF for reference and ground To the upper part of the ear or through the earlobe that runs through the cable 6. Alternative locations outside the skull include the nose near the facial skin and the neck as a mastoid. REM 4 and active EEG 5 may be attached via conventional medical device electronic snap or other simple press electromechanical connection. The REM 4 and the cable 6 may also be attached to the headband 2 via a Velcro hook / ladder press closure. In the rear of the headband, a piece of Velcro or similar press fit closure 8 can be used to secure the headband to the head of the human body with a secure, comfortable but tight mechanical fit. In an exemplary embodiment, the headband 2 is made of Fabrifoam's unique fabric-foam double-layer material which is easily stretched and is very comfortable on the skin due to its unique inherent moisture penetration properties Lt; / RTI &gt;

8, the headband 80 has the REM 83 attached as before, but here it is located on the temple 81 or otherwise at the position 82 about the head and is located in the headband (not shown) 0.0 &gt; 80 &lt; / RTI &gt; In this embodiment, two, three or four channels of EEG data may be recorded to monitor both the brain half and other spatial locations. The ear clips 87 and interconnecting cables 85 for REF and GND ear contacts are as previously described.

Figure 9 provides a series of alternative electrode configurations. Figure 9a provides a pair of views of an alternating electrode configuration in which a regular circular electrode is divided into two semicircles or alternatively a square or rectangular electrode is divided into a plurality of squares or rectangles. Figure 9b shows a diagram of an alternate electrode configuration in which the circular form is shown as a 120 degree arc and the rectangle as a square as shown below in Figure 9a with three identical conductor segments separated by insulators divided. Figure 9c shows a diagram of an alternating electrode configuration in which a regular circular top or square electrode (below) is divided into four identical conducting electrodes according to the geometry and again four independent electrodes It is divided by an insulator to make. For example, by way of non-limiting example, the four divided circular electrodes may look like the quadrants of Figure 9c, while the four divided square electrodes would look like the array of conductive electrodes shown in Figure 9c below. Hence, if two independent electrode clusters are to be used, they can be easily connected along the skull region under the support headband of the REM module, with good mechanical and electrical connectivity, according to each one according to one of the examples shown in Fig. Four channels (with two electrodes at each of two positions), six channels (with three electrodes at each of two positions), or eight channels (with four electrodes at each of two positions) in the same physical space as possible A data acquisition system may be deployed.

In addition to the head-based REM, the body electronics module collects body data.

One embodiment of the present invention provides an electronic module that collects biological signal data related to the brain / skull while the head REM collects body data about the back, chest, or neck of the back, . &Lt; / RTI &gt; For example, during a series of concussion, the human body undergoes a vestibular or balanced evaluation while the human body is under the control of the Balanced Error Scoring System (BESS) You can be asked to stand on a solid surface in a variety of matching postures. During the task, and while EEG sensors collect simultaneous EEG data rather than subjectively scoring and evaluating the human body for various subjective errors as the exercise trainer or manager is currently doing, the multi- It is possible to measure the objective biological signal of the stability of the human body based on movement and motion.

Similarly, accelerometers and / or other position / motion sensors that are positioned spatially along the torso, spatially from the neck to the chest, back to back, etc., enable more objective measurement of body movements and from there to an elastic or unstable surface While also assessing the human body's ability to respond to changes when asked to stand, the accelerometer and gyrometer in the head REM continue to measure brainwave and head stability during the task.

In one embodiment, additional accelerometer data is collected by the torso REM attached to the waist or waist back, while a third REM attached to the chest or neck is positioned at each of the body positions (head, neck / chest, waist / ) Further quantifies the balance capability of the human body simply, quantitatively, and inexpensively using a 3, 6 or 9 degrees of freedom system. In addition to performing these balance-related tasks on a hard surface, using an inflatable disposable pillow or air cushion made of sturdy plastic can be used to evaluate the human body on a clean, unused, uncontaminated, Providing an inexpensive means of doing so. When reusable foam cushions, such as the Airex model cushions recommended in the BESS guidelines, are allowed, reusable foam cushions are excellent second surfaces for A to B comparisons. The use of an inflatable elastic pillow device that is compact, disposable, inexpensive, and which the body can stand on when it is not acceptable for repeated use by multiple people, such as in medical measurements and evaluations, It can be helpful to evaluate the nervous system and is part of the present invention. Here, the same A to B comparison is possible, but has the added benefit of using a disposable, unstable surface once, like an inflatable air pillow.

REM module includes microphone and / or camera

In one embodiment, additional data converters are embedded in the REM module so that the system can obtain various streams of biosignal data. One particular embodiment involves including one of the use of an acoustic microphone coupled to an analog-to-digital converter or a digital microphone having essentially the same functionality and designed in a single package for easy integration into a REM electronic device. Typical digital outputs are common standards such as RS-232, UART, SPI and I2C for local serial digital communications. The advantage of this embodiment is that the timing adjustment by the local embedded MCU of the REM is typically more tight and more precise than can typically be achieved by peripheral MCUs such as Apple iPad, Android Tablet, or Windows notebooks Is less than milliseconds (one thousandth of a second), which may approach microsecond timing accuracy, although not exceeding microsecond (one millionth of a second) or less timing accuracy. If someone does not want to run a special "real-time" implementation of the operating system (for example, Apple iOS does not yet have a real-time OS that programmers can program control of) Yes.

In Figure 10 we can see the rendering of a head-based REM module powered by AAA batteries. Alternatively, for thinner and more compact profiles, the REM module can be powered by coin-shaped batteries. In addition to the standard "power / pairing" switch 92 and the power / pairing indicator LED 94, a front-facing digital image sensor 98 (essentially a movie camera) as well as an acoustic microphone 96 ) Are integrated. The microphone 96 can capture the sounds of the surrounding area of the human body, which sounds can be captured by the microphone 96 as a non-limiting example of the sound of the administrator, the software narrator, (Human body to be scanned). In addition, coughing, sneezing, laughing, and falls are captured in real time with tight precision, as managed in hardware by embedded MCUs in real-time data acquisition environments.

The image sensor 98 may acquire faster or video rates of the image data. The view of the image depends on the position of the REM on the head and the orientation of the human head. The use of a video image may enable tracking of the eye in the sample or may update the rate of the sensor, typically to 60 fields per second or interlaced NTSC video device at 30 frames per second . That is, spatial sub-sampling of the sub-region of interest of the CCD pixel array greatly facilitates full frame or field rate, allowing for smaller field-of-view 60, 80, or even 100 Hz sample rates , Which can be beneficially focused for the analysis of intermittent motion for distraction or other neuropsychological tests that have been widely published in the scientific literature. Of course, the microphone 96 or the image sensor 98 may be used alone or in combination with various REM modules depending on the particular situation.

Use of Google Glasses or other eye tracking device to monitor eye movement

With recent developments, Google has launched an eyeglass-like device that can project images, track their eyes, and move the camera to where people are looking. This kind of technology can be integrated into the REM or the electronics of the REM can be integrated into devices such as Google Glass to combine eye tracking performance with other biological sensor data streams. This may be particularly useful when you want to evaluate the scientific tracing quality of the eye's nerves by the brain. Visual intermittent as designed with Peirce test, King-Devick test, Developmental Eye Movement test or oddball or mismatch intermittent exercise test. It is well known that motion provides a meaningful stream of eye gaze information. These systems do not compete with the high end 128 or 256 sam / sec systems embedded in the goggles and other form factors dedicated to this task, Represents one or more bio-signal data streams that can be analyzed with the data stream.

In Fig. 11, a block rendering of a side shot of the Google Glass device can be seen. The surround member 114 is essentially a component that surrounds the head circumference from ear to ear, from which all other components are supported. The pairs of nose pads 118, 120 support the device over the nasal bridge, much like glasses. The electronics module 116 is hung down and encircles the video camera 112 and 9-axis motion sensing unit 117 (Invensense 9650, including a 3-axis accelerometer, a 3-axis gyrometer and a 3-axis electronic compass) All. A glass screen and possible eye tracing reflector / sensor 110 (shown as a dotted line rather than a solid line because it is actually transparent) is on the right side of the field of view. Within the Google glass device, the eye tracking sensor or system 111 can be used as one or more elements of the biosensor data stream in the present invention and can be used in particular for Pierrce intermittent exercise, King-Devic test, DEM), or their proprietary remedies, to monitor the location of the eyes or eyes during visual tasks based on neuroscience intermittent motion.

The motion sensing unit (MSU) 117 included in the Google Glass, when performing a dynamic balance task, such as a static balance task or a "walk around" task, The above elements can be used in the present invention. These additional biosensors need to be integrated into the overall multimode system by streaming data over a wired or wireless connection to an MCU embedded in the REM, as described elsewhere herein. The electronic module 116 of FIG. 11 can accommodate an electronic device for the head REM, which functions as an MCU having attachable electrodes positioned on the forehead as an adhesive to record an EEG bio-signal data stream. Bluetooth, ANT, Zigbee and WiFi are both short-range wireless connectivity options, as well as direct connectivity options using small connectors such as USB micros or smaller.

It is also contemplated that the data resides on an SD card that is removable from the electronic system or REM and is not transmitted wirelessly, but rather can be stored locally on a removable mass storage device such as an SD card. This alternative has the advantage of not requiring a wireless connection, but it relinquishes its ability to synchronize from the interaction with the stimulus and to monitor the data stream in real time. Each "use case" is often different, and in some cases it may be advantageous to have a local SD card storage, but in other cases it may not. As a non-limiting example, it may be advantageous to store locally if the patient is to be monitored for possible seizures during the 24- to 48-hour period of walking biosensor monitoring. Therefore, in this purely passive monitoring application, stimulation or probe presentation is not so important and the use of peripheral MCUs such as tablets or smartphones may not be necessary.

Examples of sensory and cognitive stimulation of activated patients

Applying sensory stimuli to the patient provides a more focused and detailed assessment of multimodal biological signal data streams. A signal based on an accelerometer, a temperature signal, a pulse oximetry signal, an eye gaze signal and other biological signals before, during, and / or after a patient's response to a sensory stimulus or cognitive challenge are simultaneously obtained Multimodal data can be obtained by measuring the EEG signal at the same time.

Light stimulus

Visual stimuli, such as light stimuli through the presentation of a light stimulus or a particular type of emotional photographic imagery while the body's eyes are wrapped around the head, neck / chest, waist / back, various REM units on the hand / wrist or foot / (Such as a computer, tablet PC, mobile phone, or other custom dedicated device with a microprocessor and wireless connection) that is used to collect wireless biosignal data from the wireless microprocessor device (MCU) Can be utilized. In one particular embodiment, the Google glass display is used to stimulate the right eye with a variety of spatial and temporal frequency light stimuli, as opposed to the possible stimulation on the asymmetrical left eye without a glass display. This asymmetry can be leveraged to conveniently stimulate and record the human brain from Google Glass.

12, an independent LED 122, a pair of LEDs 126, three combinations of LEDs 130, or LED arrays 128 are connected to a head REM (not shown) Mounted on the front of the module 124 and angled forward or slightly downward from the forehead so that the mirror or glass surface from the video monitor is capable of reflecting light output from the LED to the eye As shown in FIG. The advantage of this kind of approach is that dedicated LED drivers can be accommodated in the REM and used in a peripheral MCU operating system (MS Windows, Apple iOS or Google &lt; RTI ID = 0.0 &gt; More orders of magnitude of the LED (s) than are typically possible from the &lt; / RTI &gt; Non-real-time OSs are generally not compared to embedded real-time controllers. The built-in real-time controller can be used in a range of sub-milliseconds, sometimes even microseconds instead of the typical 10-50 millisecond latency range of Microsoft Windows, Apple's iOS or Google's Android non-real-time operating system Indicates jitter.

In addition, by using three primary color LEDs (red, green and blue LEDs), you can create a color combination that slides across almost all colors of the rainbow spectrum and blend the LED output roughly to create a rainbow of colors in the electromagnetic spectrum Thereby enabling selection of a color stimulus of light. Importantly, white light can be made by superimposing all three wavelengths of light at the same amplitude. This allows built-in software to control the REM MCU over a Bluetooth link and to control the LED output via anything with a much shorter latency than the previously mentioned Windows, Apple or Google operating systems, or a real- There is an advantage.

Visual stimulus

In one particular embodiment of the present invention, photographic images with desirable emotional response characteristics are presented. In one embodiment, photographic images were artificially manipulated by software, such as Adobe Photoshop, in an interesting form. The photographic images are then presented as a continuous image to assess the quality of the individual's mood or emotional response during the evaluation. For example, after the pig image has been modified to add wings, the waves can be superimposed on the sea surface. In this way, during the assessment, the human body will see the proposed "flying pig" and draw a smile from a normal, normally healthy person, since they normally do not see pigs coming out. Alternatively, the body may not respond in a normal or normative manner when someone is less emotional, mood or emotional dysfunction, unbalanced or abnormal, and perhaps suffering from concussion or mild traumatic brain injury. These modified responses to photographic images can be biologically characterized, measured, monitored, and observed through a variety of biological signal data streams from various sensors within the head REM module or peripheral REM module. In particular, Galvanic Skin Conductance is an emotional (non-irritating) sensation because the biosensor measures the skin conductivity that changes when anxiety (sweat or sweat of the skin), fear (also sweat or skin sweat) It is an excellent means to evaluate the reaction.

Thus, in this manner, consecutive images ranging from short dips such as N = 4 images to long dots such as N = 30 images can be captured at a predetermined frequency (e.g., 0.1 Hz or 0.05 Hz) And may be presented to the human body with a time delay between conversions (e.g., in some cases, displaying for 15 seconds each, or in other cases, for 3 seconds).

As another example, an International Affective Picture System (IAPS) may be utilized. The International Emotional Photography System (IAPS) is being developed to provide a set of normative emotional stimuli for empirical investigations of emotion and attention. The aim is to develop a vast set of standardized, emotionally and internationally accessible color photographs that include content across a broad range of semantic categories. The IAPS (pronounced "eye-aps") is being developed and distributed by the Center for Emotion and Attention (CSEA) at the University of Florida, The corrected photographic images have already been calibrated and utilized to provide correction stimuli from which the biometric responses and features of the human body can be quantified during the evaluation. References: Lang, P. J., Bradley, M. M., and Cuthbert, B. N. (2008). International Emotional Photography System (IAPS): An emotional ranking of instruction manuals and photographs. Technical Report A-8. University of Florida, Gainesville, Florida.

Auditory stimulation

Sound within a data acquisition microprocessor unit (MCU) (computer, tablet PC, mobile phone, or other dedicated custom device with a microprocessor and wireless connection) used to collect radiobiological signal data from REM May also be provided via a card or independently. Sound events are triggered by computer sound cards or speakers at various times so that the patient responds both to the new quality auditory stimuli as well as to the instructions as described elsewhere. This can be through an earphone or other personal listening device as well as a speaker.

As another example, an International Affective Digitized Sound System (IADS) may be utilized. The International Emotional Digital Sound System (IADS) provides a set of emotional acoustic stimuli for experimental investigation of emotions and attention. These set of standardized, emotionally and internationally accessible sound stimuli include content across a broad range of semantic categories. IADS (pronounced "eye-ads") is being developed and distributed by the Center for Emotional and Cognitive Care (CSEA) at the University of Florida. The calibrated sounds may be exploited to provide a calibrated stimulus from which the body's vital responses and characteristics can be quantified during evaluation. Reference literature: Bradley, M. M. and Lang, P. J. (1999). International Emotional Digital Sound (IADS): Stimulation, instruction manual and emotional ranking (Technical Report No. B-2). Gainesville, FL: University of Florida, Center for Psychophysiology Research.

Tasteful stimulation of taste and gastrointestinal organs

In addition to sensory stimuli of the visual and auditory sense, stimulation based on taste or tongue is also possible in the present invention. In one non-limiting embodiment, as shown in Figure 13, a cranial or other non-surgical electronic tongue stimulator of the nerve is used to activate the brain. The device is powered by a battery in the electronics housing (140). The switch can turn on the device at 152 and off at 144 while other buttons increase the power or intensity of the electronic tongue stimulus to 154 or to 142. [ The connecting member 146 delivers a signal from the electronics in the electronics housing 140 to a mouthpiece stimulator 148 located directly against the tongue. Electrodes 150 are small concentric circles of electrodes designed to directly couple with the nerve endings of the tongue. The tongue activation surface 162, which is structurally electrically connected to the connecting member 160 in Fig. 14, can be seen in greater detail. Individual electrodes 170 that directly couple to the tongue are depicted as rounded electrodes with a solid line insulator. The alignment posts 164, 166, 168 are used to align the disposable conductive plates which carry charge to the body, but which can be discarded after one use. Figure 15 illustrates such a disposable sheath 180 comprising a surface of a conducting electrode or a matched plate. A grid is aligned with the grid on the device by an alignment post or fixture 182, 184 (the third post in this figure is not indicated by the reference numeral).

An exemplary actual device of such a device is referred to as a PoNS device developed by the Tactile Communication & Neurorehabilitation Laboratory (TCNL) of the University of Wisconsin. The PoNS is a battery-powered device, located in the mouth where thousands of nerve endings on the tongue can send messages to healthy areas of the brain. The idea is that, in combination with exercise therapy, stimulation helps the brain to form new neural connections to restore function such as balance and exercise. Such techniques are essential for people with multiple sclerosis (MS), cerebral palsy, traumatic brain injury, paralysis and Parkinson's disease. In the present invention, a PoNS device can be used to stimulate the brain through the tongue's nervous response rather than auditory stimulation, visual stimulation, balance-based stability tasks, or cognitive tasks as described above. Responses across a variety of biological signal measurement data streams can be quantitatively and accurately obtained. Once acquired, the new signal can be analyzed and compared to any of the other norms generated from previous measurements, populations, or reference values in the same human body. It is noted that by using PoNS devices or other tongue-based electrical stimulators designed for brain health assessment, the neural connections of the brain and tongue can be directly evaluated without the use of food and in a more reproducible and quantitative manner.

A PoNS device or other tongue-based electrical stimulator may be connected to the peripheral MCU either directly via radio means with a Bluetooth radio or other RF connection means (ZigBee, ANT, WiFi, proprietary) or via bidirectional communication with the head REM module Lt; / RTI &gt; The head REM module is then coupled to a local MCU (e.g., a TI MSP430 16-bit microprocessor or any of a variety of ARM Cortex M series microprocessors such as ARM Cortex M3, M6, M8) of a head REM module (or other REM module) Lt; RTI ID = 0.0 &gt; PoNS &lt; / RTI &gt; or other electrical tongue stimulators. In an implementation where the software embedded in the REM module controls the signaling to the nerve stimulator, the accuracy and timing will be significantly improved for all the same reasons described above compared to a traditional non-real-time operating system.

Olfactory stimulation

The olfactory stimulation means may be using UPSon cards or cards of Sensonics. Here UPSIT represents the University of Pennsylvania Smell Identification Test and provides the person's nose with olfactory stimulation at a predefined time indicated by the instructions provided by the peripheral MCU software. This may include smelling or scratching each of any number of cards with a smell as predetermined and indicated. The results are automatically recorded by the various multimode biological sensor data streams being generated from the body during the evaluation at that time.

In a more automated manner, olfactory-based stimulation is also possible in the present invention. In one non-limiting embodiment, as shown in Figure 16, a non-surgical electronic nose or olfactory bulb stimulator is used to activate the brain. The device is powered by a battery in the electronics housing (198). The switch can turn on the device at 212 and turn off at 202 while the other buttons increase the power or intensity of the electronic nasal stimulation to 214 or 200. The connecting member 206 delivers a signal from the electronics within the electronics housing 198 through the connector 204 to the thin and flexible nose piece stimulator 208 located immediately in the olfactory receptacle. The electrodes 210 are small concentric circles of electrodes designed to directly couple with the nerve endings of the olfactory nerve. The nose activation surface 226 that is structurally electrically connected by the coupling member 220 and the nostril support 222 in Fig. 17 can be seen in greater detail. Individual electrodes 226 that directly couple with the olfactory receptors are depicted as round electrodes with solid insulators. Align posts 228 are used to align the flexible disposable conductive grid used to deliver electrical charge to the human body. The conductive grid may be integrated into a disposable sheath 224 (which is sufficiently long to prevent the reusable device from touching the human body) that can be discarded after one use.

As a neurological diagnostic procedure, transcranial pulse current stimulation

Another embodiment of the present invention is a means for stimulating the brain by stimulation of the skull. One such commercial device, the Fisher Wallace Cranial Brain Stimulator, provides electricity for micro-currents to help people with insomnia, anxiety, depression and pain issues. These devices and approaches can be used to stimulate the brain and measure the brain's response to skull stimulation. By way of example, and not by way of limitation, the system, apparatus and methods of the present invention can scan the body in a series of tasks prior to receiving stimulation of the skull from Carter Wallace or an equivalent brain stimulator, After 20 minutes of treatment, the body can be re-scanned and the response measured according to the skull stimulus. Based on these reactive signatures, biomarker differences can be derived for both healthy, healthy populations as well as disease, injury or disability populations. Signatures derived from this double scan approach can be used by diagnostics for one of a variety of intended uses. By "diagnostically" may mean as many as ten different intended uses as defined above.

Specific examples of such approaches include concurrent brain / traumatic brain injury, migraine, mild cognitive impairment and dementia, pre-exercise (pre), as well as various neuropsychiatric conditions such as depression, manic depression, schizophrenia, anxiety or panic disorder, -motor) includes the use of a stimulator of the skull to assess Parkinson's disease by diagnosis. This approach may also be useful for the treatment of diabetic disorders such as multiple personality disorders, dyslexia, hallucination, phobias, addiction, alcohol abuse, anorexia or bulemia, obsessive-compulsive and mood disorders It may be useful to diagnose the mental disorder of the brain including the disorder.

Transdermal pulsed current stimulation of the peripheral nervous system as a neurological diagnostic procedure

The present invention also contemplates the use of transcutaneous pulse current stimulation in the form of peripheral stimulation, such as a TENS unit. This is because, besides the diagnosis of central nervous system issues, it can have an important diagnostic effect on people with peripheral nervous system issues. The results are automatically recorded by the various multimode biological sensor data streams generated from the body under evaluation at that time.

In a particular embodiment of the invention, the TENS unit is attached to the left and right finger pads known to have many nerve endings and is stimulated in a characteristic manner. Responses related to the brain synchronized to the peripheral stimulus are collected in the form of an EEG brainwave sensor, electrical skin conductivity, pulse oximetry, cerebral blood flow, temperature, and other biosignal data streams. If the TENS stimulus has temporal cyclic activity, a locked-in signal can be examined and a phase delay between the peripheral TENS stimulus and the biosensor response can be found.

Use of multimode systems to generate multimodal signatures for disease or injury

The system of the present invention can be used to create an extracted biometric table that includes features extracted from multi-mode biological signal data. As a non-limiting example, a group of human subjects experiencing concussion (mTBI) or mild traumatic brain injury and two groups of human beings, such as Group B, who has no such experience and acts as a control (CTL) Under the supervision of. Participants in both groups A and B were equally scanned with an electronic REM module containing a single electrode EEG. A 5 minute protocol was performed, including a 30-second eye closure, a 30-second eye-lift, a King-Devic test for approximately 3 minutes, a 30-second eye closure followed by a 30-second eye lift. For each card in the King-Devic test, the stopwatch time and error were manually recorded by the test manager, while a nearby MCU (notebook computer) presented the card and recorded the responses of the individuals via the microphone. Data was confined to participants for the purpose of artifact detection, signal processing and feature extraction. The extracted feature data tables were then quality adjusted and refined to eliminate as many errors as possible. The total time for the King-Devic test was generated as one extracted variable and received a logistic classification model. The results of these models indicated that the king-devic time alone predicted a classification of approximately 62% of the time individuals. Independently, in each of the delta, theta, alpha, beta and gamma bands, relative power was analyzed in a logistic classification model where the EEG feature was the predictor variable x-variable and the clinical outcome (group A or B) Dependent y-variables or results. Analysis was performed in JMP Pro v10 from SAS (Cary, NC).

FIG. 18 shows a logistic plot 420 of relative beta power (from 12-30 Hz) showing reduced relative beta power in concussion group A for control group B. FIG. When configuring the receiver operating characteristic (ROC) curve 430, the EEG characteristic alone is calculated to be approximately 65 (%) of the time as defined by the summary ROC region (summary ROC Area Under the Curve % Accuracy.

Figure 19 shows that when the King-Devic final test seconds (cognitive measurement of the target brain) is combined with the associated beta EEG power (EEG measurement) to generate a multi-modal signature, the area under the curve (AUC) And an ROC plot 440 that is currently 70%. Adding age and sex co-variates, the AUC rises to 76% as shown in the ROC plot 450 and fully confirms the system and method of the present invention. By adding additional aspects of information from either the accelerometer, the microphone in sound analysis, or the camera for eye tracking or image analysis, it is expected that the accuracy of the predictive model will be further increased by assisting the clinician in the diagnosis of a given condition. can do. This illustrates the power of a multi-mode system of a target biosensor for measuring brain health and function.

Use of time-series correlation in multi-mode biosignal data streams

The present invention also explicitly contemplates using two points, three points or more order correlation to time interrogate interactions between various biosensor data streams. For example, consider time-series samples from a microphone sampled at 8 KHz, consider an EEG from a single lead sensor sampled at 512 Hz, and compare the two available from the literature or MATLAB toolbox Any of the correlation functions of the points may be considered. Since biosensors can be spatially located elsewhere or temporarily, if different data streams occur with real-time simultaneous or computed time delays (sometimes called phase shifts) between variables of interest, It should be noted that spatial variables can be utilized. In addition, although techniques such as spatial coherence and concordance can be used between two sensors of the same modality (commonly used for EEGs), respectively, Mode stream of biosignal data in a mode different from that of the bi-directional mode.

As the CPU processing power is increased to smaller form factors, it is possible to reduce the complexity of the multiprocessing system by means of an embedded digital signal processor (DSP) and other high-end MCU devices embedded in the REM or trunk REM You can imagine the real-time processing of the biological signal data stream.

Use of the infrared eye tracker in neuro-opthalmologic tasks

Other approaches to the Google Glass Eye Tracker include the use of other dedicated hardware such as those from Tobii, GazePoint, or other Eye Tracker products, which measure both the left and right eye position and the pupil diameter Streams continuously. From the output eye gaze position, fixed measurements can be made for various objects in the stimuli field of view, as well as for anti-saccades or intermittent movements of interest. Stimulus vision can include instruction, static photographs or artistic creations, movies, web pages, advertisements, pdf documents, and so on. A predefined area of interest (AOI) can be created, and eye gaze data can be superimposed on top of the area of interest to define fixed and intermittent motion metrics for the AOI. The candidate metrics may include a first fixed time, a fixed duration, a total fixed duration, a visit duration, an entire visit duration, a fixed duration, a fixed duration, The accuracy of the intermittent motion, and the accuracy of the semi-intermittent motion. These extracted features can then be combined into a summary feature table of the present invention and can include a multi-variate signature and a classifier along with extracted brain wave features, speech recognition features, neuropsychological test data, accelerometer- ). &Lt; / RTI &gt;

Examples

The foregoing description includes numerous details which are not to be construed as limiting the scope of the invention, but merely as exemplifications of the disclosed embodiments. Many alternatives are possible within the scope of the present invention. The following examples are intended to help a person skilled in the art to make, use, and carry out the invention.

Example 1. TIRHR concussion study

In collaboration with a nonprofit-based healthcare facility near Lake Tahoe, two groups of subjects were enrolled in a clinic protocol approved by the Institutional Review Board (IRB), where the first group of subjects (group A) (mTBI) or mild traumatic brain injury, and the second subject control group (Group B) was enrolled as a person with no brain-related problems and served as a control group (CTL) selected under IRB supervision Respectively. Participants from both groups A and B were equally scanned with an electronic REM module containing a single electrode EEG device as disclosed in PCT patent application PCT / US2012 / 046723 (filed July 13, 2012). The 5 minute scan protocol is terminated by 30 seconds of snow closure, 30 seconds of blinding, approximately 3 minutes of King-Devic test, followed by 30 seconds of eye winding and 30 seconds of blinking. The stopwatch time and errors for each card in the King-Devic test are manually recorded by the test executive while the nearby MCU (laptop computer) presents the card and records the individual response via the microphone. The head-based REM module continuously records the forehead EEG from position Fp1 for the ear protrusion for the reference REF and ground GND. The data is locally encrypted before it is moved through a secure pipe to a virtual server on cyberspace.

Signal Analysis Scientists were blocked for attendee clinical diagnostics for artifact detection, signal processing and feature extraction. The extracted feature data table is then quality-controlled and scrubbed to eliminate as many errors as possible. The total time for the King-Devic test is calculated according to a known procedure for summing individual times to read all three cards in succession using a minimum of error. This total time represents one extracted variable and experiences a logistic classification model. The results of this model show that only King-Dick's total time predicts an individual classification of about 62% of the time (AUG = 0.62).

Separately, an analysis of the parallel data stream of EEG EEG information sampled at 128 samples per second with a 10-bit amplitude resolution is Fourier transformed to determine spectral characteristics. Relative power in each of the delta, theta, alpha, beta and gamma bands is analyzed in a logistic classification model where the EEG feature is the predictor variable x-variable and the clinical outcome (group A or B) . This analysis was performed with JMP Pro v10 from SAS (Cary, NC).

In FIG. 18, a logistic plot 420 for the relative-beta power (from 12-30 Hz) showing reduced relative beta power in concussion group A for control group B can be seen. It can be seen that when interpreting the recipient manipulation characteristic (ROC) curve 430, the EEG feature alone predicts about 65% of the time as defined by the summary AUC statistics. 19, when the King-Devic test time (cognitive measurement of the target brain) is combined with the relevant beta EEG power (EEG measurement) to generate the multimodal signature, in the ROC plot 440, Is currently 70%. Adding age and sex co-variates, the AUC rises to 76% as shown in the ROC plot 450 and fully confirms the system and method of the present invention. By adding additional aspects of information from either the accelerometer, the microphone in sound analysis, or the camera for image analysis, it can be expected that the accuracy of the predictive model will be further enhanced by assisting the physician in diagnosing a given condition . This illustrates the power of a multi-mode system for measuring brain health and function.

Example 2. Lehigh University Sports Medical Concussion Study

In collaboration with NCAA Division 1 colleges, several groups of subjects were enrolled in the IRB approved clinic protocol, where the first group of subjects (Group A) were clinically diagnosed with clinical concussion (mTBI) or brain trauma due to mild trauma , The second subject control group (group B) was enrolled as a person who had no problems associated with concussion, served as a non-injury control subject (CTL), and other players from another sport ) Were likewise selected under the supervision of the IRB. Participants from groups A, B, C and other groups were equally scanned with an electronic REM module containing a single electrode EEG device as disclosed in PCT patent application PCT / US2012 / 046723 (filed July 13, 2012). The 22-24 minute scan protocol is based on concussion standard assessment (SAC), which includes 1 minute blindfold, 1 minute blind, graded symptom checklist from SCAT-2, direction, immediate memory call, mental focus, , For a full balanced error scoring system (BESS, for both hard and foam surfaces), a King-Devic test card, binaural bits at 6 and 12 Hz bit frequencies centered at 400 Hz Audio stimulation, stimulation by light, and a moving red cross for one minute.

The stopwatch time and error for each card in the King-Devic test is manually logged by the test executive, while the nearby MCU (Dell Vostro 3550 laptop computer) presents the card and responds to individual responses via microphone and mouse clicks. Record. In addition to the SAC response, a BESS error is logged manually. The head-based REM module continuously records the forehead EEG from the twenty montage position Fp1 for the ear protrusion for the reference REF and ground GND. The multimodal evaluation is recorded according to which task is being performed, consisting of the EEG data stream, the perceived data stream (action time and accuracy), the self-report of concussion symptoms, and the microphone data stream. The data is encrypted locally before moving through the secure connection pipe to a secure virtual server on cyberspace.

Signal Analysis Scientists were blocked for attendee clinical diagnostics for artifact detection, signal processing and feature extraction. The extracted feature data table is then quality-controlled and scrubbed to eliminate as many errors as possible. The total time for the King-Devic test is calculated according to a known procedure for summing individual times to read all three cards in succession using a minimum of error. This total time represents one extracted variable and experiences a logistic classification model. A series of evaluations were performed on the concussion-side athlete and the control side with three to ten scans evaluating both the concussion side and the control side.

As can be seen in Figures 20 and 41 for the overall score of the graded symptom checklist, some subjects were found to be both benign and normal for the symptoms, while others (such as subject S16 in Figure 20) And showed dramatically elevated levels of symptoms consistent with my symptoms. Figures 21 and 42 show the overall score from the concussion standard assessment (SAC) along with the maximum health values of 30 points plotted along the y-axis in time series measured at several different scan visits along the x-axis Show. Some subjects (e.g., subject S07 in FIG. 20) may be considered to be cognitively intact (e.g. subject S03 in FIG. 20) while horizontal trajectories approaching 30 (full score) And it seems to be a cognitive problem. In Figures 22 and 43, the BESS total error score (summed over all three postures on a rigid surface and foam surface) is plotted over time during a scan visit (which means that the same time interval between them But not necessarily). While the horizontal trajectory observed to be close to 0 (full scale) appears to be relatively stable within their vestibular system, some subjects have had meaning over time until they have stabilized within a few oscillations around normal operation It appears that the balance and vestibular problems are consistent with the concussion, which is indicated by an increased number of errors reduced by a slope.

The last piece of this data can be seen in Figures 23 and 44 where the total time (summed over three test cards in a few seconds) of the King-Devic Optimal Logic Test (Oride et al. 1986) Lt; RTI ID = 0.0 &gt; scan &lt; / RTI &gt; The horizontal trajectory, which rotates at a minimum value (typically 40 seconds), appears to be consistent and stable in their neuro-optometric logic processing and usually represents a healthy non-injury control subject whereas some subjects (e.g., S01, S12 ) Appears to take longer in an early scan visit, followed by a steady, consistent amount of time to calm down and consistent with a concussion phenotype that recovers brain damage from days to weeks and a baseline level of performance. FIG. 45 shows a pair of views of the same data in FIG. 44, in which the concussion-side subject and the non-injured teammate control comparator subject are plotted together.

As is clear from the previous four sets of data in Figures 20-23 and 41-44, the symptom data stream, the perceived data stream, the balance / vest data stream, and the neuro-optometry logic data stream are consistent with the present invention Gt; &lt; / RTI &gt; can be combined with a multivariate composite. Moreover, the cross-correlation and prediction model may be derived from these and other biosignal data streams, including EEG data streams and microphone data streams but not included in the depicted analysis.

An additional analysis that pairs the concussion side with the non-impaired side control subjects together can reveal the information of interest as shown in Figures 24-27, &Lt; / RTI &gt; are the same four matrices that are plotted in pairs. Interestingly, FIG. 28 shows the relative beta power in nine pairs of players, with red indicating the concussion side player and the non-competing peer control side being green. The results appear to be mixed with some subjects (eg, A pairs, E pairs, G pairs) representing literature reporting relative beta decline in TBI. Moreover, an analysis of the baseline adjusted first scans after the "estimated event" can help estimate the estimated concussion in the human body shown in Figs. 29-33.

For example, in FIG. 29, it is clear from the limited sample that the GSC elevated from visit 1 to 5 or more is distinct for the concussion side subjects but not for the control side. Thus, very limited data support a predictive biomarker with GSC total (Visit1) - GSC total (baseline = visit0)> 5 as "likely to be a concussion". However, when reviewing the additional data from Figure 41, it is possible to perform item analysis of each question in the GSC and determine whether the most important element or question (least important to least important order) in the GSC is 1) "headache" 4) "slowed down" 5) "embarrassed" 6) "pressure on the head" 7) "dizziness" 8) "difficulty concentrating" . 9) "fatigue", 10) "sleepiness", 11) "light-sensitive". If you do not want to shorten the GSC in time and pair up a number of questions and reduce the discriminatory power, then you need a shortened " GSC-short ".

From Fig. 30, the concussion-side athlete does not show a clear change from the reference value for the standard evaluation of the concussion as a whole. However, if you analyze the individual components of the SAC, you know that the most important SAC elements (most important to least important line) include delayed memory, concentration, SAC total score, immediate memory, and direction. Thus, if we want to shorten the SAC while maintaining differentiating power diagnostically, we can include only delayed memory and instant memory elements of the SAC in the shortened SAC, but otherwise contain the concentration components as well. Directional elements do not seem to give a distinctive power.

31, the BESS total error score is a variable that does not seem to be reliable in this small sample of the human body. Additional data is now available from that shown in Figure 43, which supports the previous view. If you examine each of the six elements of BESS (from the most important to the least important), the elements are BESS-TandemStance-FoamSurface, BESS-TotalErrors, BESS-SingleFoot-FoamSurface, BESS-SingleFoot-FirmSurface, BESS-DoubleStance-FoamSurface , And finally BESS-DoubleStance-FirmSurface. So, if you use foam, the task will be reduced by 50%, which seems to help.

From Figure 32, the total time for the K-D task appears to be quite variable with limited data as well. However, if we include the results from Figure 44, it seems clear that intermittent exercise-based card tasks are an important means for differentiation.

In addition, in Fig. 34, the combination of four non-damage control subjects can show a pattern of interest with five modes of data appearing graphically. In FIG. 35, a combination of four mTBI-damaged subjects can show a pattern of interest with five modes of data appearing graphically. Finally, a direct comparison of one non-injured player with the injured (mTBI) player can provide an observational signature that can distinguish individuals in different groups. 36, GSC, SAC, BESS, KD time and relative beta power (along the y-axis, each from top to bottom) are individually stacked on top of each scan visit (along the x-axis) Return-to-Learn, Return-To-Play, Return-to-Work, Return-to-Duty, and Return-to-Activity decisions.

Example 3. Rothman concussion study

In collaboration with clinical practice and concussion specialists, two groups of subjects were enrolled in the IRB approved clinic protocol, where the first group of subjects (Group A) was clinically diagnosed with concussions (mTBI) or mild trauma And the second subject control group (Group B) were enrolled as those who did not have a problem associated with concussion and were selected under IRB supervision to serve as the control group (CTL). Participants from both groups A and B were equally scanned with an electronic REM module containing a single electrode EEG device as disclosed in PCT patent application PCT / US2012 / 046723 (filed July 13, 2012). The 25 minute scan protocol involves 1 minute of snow, 1 minute of blind, followed by about 25 minutes of scanning, during which time the student athlete is immediately in the vicinity MCU (Dell Vostro 3550 laptop) I have completed the ImPACT computer test. Key-clicking on the peripheral MCU laptops marks the start and end of time for each of the various tasks within the ImPACT computer evaluation. This represents another multimodal assessment combining neuropsychological tests, EEG, and clinical observations in accordance with the present invention.

Example 4. Performing Google Glass in Borealis Software

In collaboration with BrickSimple LLC, we launched Borealis, our Android application software running on Google Glass as a glass product, which is a built-in 3-axis gyrometry and 3-axis electronic compass - Enables connection to a variety of bio-sensors such as the axis Invnesense accelerometer. This combination of biosensors made it possible for software running on glass to make medical and healthcare measurements and report them in a responsive way. We successfully deployed our app from the Android tablet to the glass-based "Glassware" and incorporated the accelerometer and blink detector. Glass-based software has also been successfully deployed on Android devices and automates software pairing and launching in the glass matching user interface.

Example 5. Tobi X2-30 compact eye tracker performance

We incorporated the Tobi X2-30 compact eye tracker into our data acquisition paradigm. Figure 37 shows a schematic diagram of a laptop PC 500 screen, which may work equally well for a tablet or smartphone form factor. The eye tracker 510 is plugged into the USB port 520 in this wired mode, and a Wi-Fi or other wireless connection can be performed similarly. First, the stimulus is generated to check the analytical performance of the eye tracker under extreme conditions. The numbers appear on the slides at the corners of the screen and during the 2-second interval before moving to the next corner with clockwise rotation. The eye position is plotted with respect to the average eye as shown in FIG. The output of the eye tracker produces the expected trajectory very well with an apparent 16: 9 aspect ratio at the asymmetric x and y positions.

In subsequent experiments, the neuro-optometry logic intermittent exercise card (King Devic test) records the forward-facing webcam on the EEG brain waves, microphone, and laptop while being presented. Figure 39 shows a heat map representation in the case where the line of sight is timely focused on the number of stimuli in the various cards. Thus, while the brain reads numbers from the car, fixation takes place in time, while the eye gazes at a point spatially rather than moving from fixture to fixture, such as intermittent motion. FIG. 40 shows a flow chart of a method of generating an image of a subject using a variety of predefined (or predefined) criteria to enable an extractable biomarker measurement of an eye that interacts with an AOI (region of interest) to limit the duration, duration and accuracy of intermittent and fixed motion as the subject tries to track the target of interest. (Indicated by a circle centered on the number on the card). In FIG. 40, we can see the emergence of a remarkable line of sight where an "off-target" occurs at the end of the same column at the beginning of a given column. Thus, it can be clearly seen that the accuracy percentage for the first number on the left side of a row is a biomarker that is as good as a percentage of the time outside the first number. Features extracted from most numbers on the right at the end of a given column on the card will be less important.

It will be appreciated by those of ordinary skill in the art that the present invention may be applied to and may be modified for other uses without departing from the scope of the present invention. For example, the signal processing described herein may be performed in a server, in a cloud, in an electronic module, or in a local PC, tablet PC, smartphone, or customer portable device. Accordingly, the scope of the present invention should not be limited to the exemplary embodiments described herein but is to be limited only by the appended claims.

Claims (14)

  1. A system for capturing multiple streams of biological sensor data for assessing brain health of a user,
    An electronic module mounted on or near the user's head, comprising an active EEG sensor collecting one or more channels of EEG brainwave data;
    A plurality of biological sensors for simultaneously recording biological sensor data from a user using a plurality of biological sensors,
    A stimulation device for applying to the user at least one of a visual stimulant, an auditory stimulant, a taste stimulant, a smell stimulant, and / or an action stimulant,
    The plurality of biological sensors may include a microphone for recording human speech to capture a human oral response during a series of tasks for either a cognitive test or auditory stimulation, And an image sensor for recording the recognition identification information,
    Wherein the plurality of biological sensors simultaneously measure the response of the human body to stimulants applied by the stimulation device for recording.
  2. The method of claim 1, wherein the plurality of biological sensors are selected from the group consisting of: accelerometer measurement of balance and motion, heart rate by pulse oximetry, heart rate fluctuation, and arterial oxygen measurement, galvanic skin conductance (Or dermal conductance), a key press during a cognitive test, and perceptual data in the form of a mouse click or screen event touch.
  3. 3. The system of claim 2, further comprising a peripheral MCU in the form of a device such as a laptop computer, tablet PC, or smart phone that simultaneously captures the biological signal stream collected by the plurality of biological sensors.
  4. The system of claim 1, further comprising at least one peripheral electronic module positioned on a user's torso or limb to collect heart rate and position data registered together with data collected by the electronic module, A system in which data can be analyzed in either a manner that is independently analyzed, or a method that is correlated with one another.
  5. 2. The system of claim 1, wherein the electronic module further comprises an LED for optical stimulation.
  6. 2. The system of claim 1, further comprising a peripheral device for displaying a video or a movie to a user to stimulate a visual system, wherein the biological sensor collects the user &apos; s brain response to such stimulation.
  7. The system of claim 1, wherein the electronic module comprises multiple contact electrodes, whereby a standard circular or square electrode is evenly divided into two, three, or four independent electrodes.
  8. 2. The system of claim 1, wherein the electronic module comprises a mass storage device for storing collected biological sensor data.
  9. 2. The system of claim 1, wherein the stimulation device applies a stimulus to at least one of the user's senses, and wherein the electronic module collects biological sensor data from a biological sensor that collects biological sensor data from other senses of the user's senses.
  10. 10. The system of claim 9, wherein the stimulation device presents a photographic image to a user and the electronic module collects skin conductivity measurements, EEG waves, and / or accelerometer measurements while the photographic images are presented.
  11. 4. The method of claim 1, wherein the set of tasks is substantially similar to a "headache "," unstable ", "helplessness "," dullness ", "head tightness ", & A system of questions of "difficulty concentrating", "fatigue", and "loneliness".
  12. 8. The system of claim 1, wherein the set of tasks comprises an immediate and delayed memory task of concussion standard assessment (SAC).
  13. 13. The system of claim 12, wherein the set of tasks further comprises a concentration task of a concussion standard assessment.
  14. 12. The system of claim 11, wherein the set of tasks includes only three foam based postures of BESS total error scores.

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